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510(k) K242816

Quantium by Bisco, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2024
Date Received
September 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K163171 — CeraClean (April 14, 2017)
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  • K143292 — TheraCal DC (August 4, 2015)

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